Laboratory Result-based Adverse Event Assessment Messaging Project

The scope of this project is to develop specifications to support the messaging requirements of initial result data for laboratory result-based quantitative adverse event (AE) assessments/grading. This message content represents only the first-level evaluation of lab results subject to quantitative AE assessment. Subsequent AE investigation must be conducted within the local clinical research environment in order to determine, in part, the reporting requirements established by such entities as the protocol sponsor, the oversight committee, the regulatory agency. Thus, the messaging interaction of concern to this project is intended only to facilitate communication between an automated lab-based quantitative AE detection and grading service and a system within the local research environment such as a Clinical Trials Management System (CTMS) or Clinical Information System (CIS).

Project Artifacts

• [Scope Statement]
• [Project Charter]
• Storyboards
  • [Storyboard & Interaction Design Elements]
• [Draft Activity Diagram: Life Cycle of the Lab-based AE]
• CMET Design Specification
  • [CMET Design Specification 2007/08/07]
  • [CMET RIMM & Data Dictionary]
• [Vocabulary Domains & Value Sets]

Conference Call Schedule

Tuesday, Every other week
10am - 11am Eastern Time
Next Meeting: October 23, 2007
Phone Number: +1 (702) 894-2444
Participant Passcode: 74859677

• Meeting Minutes